JP2004216192A - Device and medical appliance - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a device and a medical appliance for reforming a tissue. <P>SOLUTION: The device 700 comprises a first member 720 and a second member 722 constructed operable at a distant portion of a flexible instrument. The first member 720 has a tissue fixing device 730 consisting of two fixing parts 824a, 824b joined to each other via a flexible member 822. The first member 720 and the second member 722 take mutual action for placing the tissue fixing device 730 in the body of a patient. The two fixing parts 824a, 824b are arranged apart a predetermined relative distance from each other. <P>COPYRIGHT: (C)2004,JPO&NCIPI

Description

  The present application relates to devices and medical instruments for reconstructing tissue, and more particularly, to reconstructing tissue near the junction between the stomach and the esophagus.

  This application claims priority from US Provisional Application No. 60 / 140,492, entitled "Gastric Elevation Method and Apparatus," both filed June 22, 1999, which is incorporated herein by reference. Co-pending US application Ser. No. 09 / 520,273, filed Mar. 7, 2000, entitled "Methods and Apparatus for Tissue Reconstruction," incorporated herein by reference, and Mar. 2000. A continuation-in-part of co-pending US application Ser. No. 09 / 519,945, entitled "Apparatus and Method for Healing Painful Physical Defects," filed on the 7th. .

  Gastroesophageal reflux disease (GERD) is a common upper gastrointestinal dysfunction in which acidic contents of the stomach flow inappropriately from the stomach into the esophagus. Reflux of the contents of the stomach into the esophagus acts on or when the gastric pressure is large enough to overcome the resistance to flow normally present at the junction between the stomach and the esophagus (GEJ). Occurs when gravity is large enough to create a flow through the GEJ. Pharmacotherapy, open surgical procedures, minimally invasive procedures, and endoscopic procedures for treating GERD are known.

  Several attempts have been made to treat reflux disease with flexible endoscopes. An early endoscopic approach to controlling GERD was to inject collagen into and around the LES. O_Conner and Lehman treated 10 patients with this method with some success, but some patients required additional injections of LES to maintain symptomatic relief. O_Conner KW and Lehman GA 1998, Gastrointest Endosc 34: 106-12. Donahue et al. Show that GERD, induced by intravenous injection of high doses of atropine in dogs, can be controlled with a flexible endoscope by injection of 5 percent sodium morphate into the proximal gastric area 1-2 cm away from the LES. Demonstrated, suggesting that proximal gastric sclerosis induced by injection forms an effective antireflux barrier. Donahue PE et al., 1990, GastrointestEndosc 36: 253-6; Donahue PE et al., 1992, World JSurg 16: 343-6. Endoscopic proximal gastric sclerosis induced by a Nd: YAG laser has also been shown to create a strong reflux barrier in dogs. MacGouranRCM and Galloway JM 1990, Gastrointest Endosc 36: 531-2. Recently, Harrison et al. Described a method of forming a flap valve in the GEL by creating an esophageal intussusception inside the stomach. U.S. Patent No. 5,403,326. LoCicero in US Pat. No. 5,887,594 disclosed an endoscopic method for reducing gastric and esophageal reflux.

  The device of the present invention comprises a first member and a second member operably configured at a distal portion of a flexible device, the first member comprising two fixed parts joined by a flexible member. Comprising a tissue fixation device having the first member and the second member interact to position the tissue fixation device within a patient's body, and the two fixation components are spaced apart by a predetermined relative distance It is a device to be performed.

  In this case, it is preferable that the flexible member is formed of a material different from the fixed component. Similarly, the flexible member is preferably composed of sutures. Similarly, each of the securing components preferably defines a hole for receiving the flexible member. Similarly, the second member preferably comprises a portion of the tissue fixation device. Similarly, the first member preferably defines two channels for accommodating the two fixed components at the predetermined relative distance. Similarly, the first member preferably further comprises two tissue piercing elements each defining the two channels. In this case, the second member preferably defines two holes for receiving the two tissue piercing elements, respectively. Similarly, it is preferable that the two fixing parts are connected to the first member at the predetermined relative distance.

  Another device of the present invention comprises a tissue fixation device having a fixation portion joined by a flexible portion, comprising a member configured to penetrate biological tissue, wherein the member is a flexible device. And a device configured to be operable at a distal portion of the tissue fixing device, and to dispose the fixing portion of the tissue fixing device at a predetermined relative distance via the living tissue.

  In this case, it is preferable that the flexible portion is formed of a different material from the fixed portion. Similarly, the flexible portion is preferably comprised of suture. Similarly, each of the fixed portions preferably defines a hole for receiving the flexible portion. Similarly, it is preferable to further include a second member including a part of the tissue fixing device. Similarly, the member preferably defines a channel that houses the fixed portion at the predetermined relative distance. In this case, the member preferably includes an element that defines the channel and penetrates the living tissue. Also, in this case, it is preferable to further include a second member defining a hole for receiving the element. Similarly, it is preferable that the fixed portion is connected to the member at the predetermined relative distance.

  Another device of the present invention comprises two tissue piercing elements and a tissue fixation device including a fixation portion joined by a flexible portion, wherein the fixation portion and the flexible portion are made of different materials. Wherein the two tissue piercing elements are configured so that the fixing portion of the tissue fixing device can be arranged through a living tissue.

  In this case, the flexible portion is preferably composed of a suture. Similarly, each of the securing portions preferably defines a hole for receiving the flexible portion. In this case, preferably, the two tissue piercing elements define a channel for receiving the fixation portion.

  Another device of the present invention comprises two tissue penetrating elements and a tissue fixation device including a fixation portion joined by a suture, wherein the two tissue penetrating elements comprise the fixation of the tissue fixation device. It is a device configured to be able to place a portion through a living tissue.

  In this case, preferably, each of said securing portions defines a hole for receiving said suture. In this case, preferably, the two tissue piercing elements define a channel for receiving the fixation portion.

  The medical device of the present invention includes a flexible coil shaft and a tissue piercing coil located at a distal end of the coil shaft, wherein the tissue piercing coil is different from at least a part of the coil shaft. It is a medical device wound in an aspect.

  In this case, it is preferable to further include a member arranged beyond the coil shaft. In this case, it is preferable that the member and the coil shaft are configured to be relatively movable. Similarly, it is preferable that the member is configured to be capable of fixing tissue.

  Another medical device of the present invention comprises an elongated and flexible coil shaft, a tissue piercing coil located at a distal end of the coil shaft, and a member disposed beyond the coil shaft. The coil shaft is a medical device configured to be relatively movable.

  In this case, it is preferable that the member is configured to fix the tissue.

  The present invention advantageously provides an endoscopic method for treating GERD without having to surgically create an entrance to access the GEJ. This procedure does not require general anesthetic treatment and can be performed as a sedated outpatient procedure. This procedure can be performed by a gastroenterologist instead of a surgeon, is less time consuming, has fewer complications and side effects, is more basic than surgical methods, and requires less cost. This procedure reproduces or reinforces the natural anatomy and can easily be restored to its original state.

  Many of the advantages of the present invention, when it is relevant to the treatment of GERD, include the reproduction of natural anatomy, reduced discomfort, increased efficacy, technical ease in clinical practice, and the like. In particular, this method replicates the flap valve structure between the normal stomach and the esophagus, avoids the safety concerns associated with methods involving stapling through the esophagus, and provides a tissue fixation device directly on the sealing surface. Can be performed by an endoscopist for individuals who are placed in a sedated state but not put under general anesthesia.

  Here, various features of the present invention will be described with reference to the drawings. Although the present invention has a particular application for reducing gastroesophageal reflux, the invention is not limited to this particular application only, but also for the stomach as well as other hollow organs described below. Is also applicable.

<A. Endoscopic treatment method for reconstructing tissue in hollow body organs>
In one aspect, the invention provides an endoscopic treatment method for reconstituting tissue in a hollow body organ. This aspect of the invention will now be described, by way of example only, with reference to FIGS. 1 to 13 which disclose the steps of the method of the invention when applied to the stomach. The method of the present invention may be applied to any hollow organ as described below. In a broad sense, the present invention relates to at least the operation of engaging the inner surface of a hollow organ to be reconstructed, manipulating a portion of the engaged tissue to perform the reconstruction, and fixing the engaged tissue. Maintaining the reconstruction achieved by The method may include an endoscope visualization step throughout or in part of the procedure. Details of the shape formed by the reconstructed tissue will be described below.

  As used herein, an “endoscopic treatment method” refers to a procedure for treating a patient, wherein treatment of the tissue to be treated is performed through a lumen. In a preferred embodiment, the endoscopic treatment method is performed without a concurrent invasive approach involving a surgical incision to reach the treatment site. This preferred embodiment involves at least the use of an intravenous catheter to administer the crystalline or colloidal solution or drug to the patient, but requires that an intraperitoneal set, such as a trocar, laparoscopic, be placed through the abdominal wall. There is no.

  The method of the present invention also contemplates accessing the interior of the patient's stomach by gastrotomy or gastrostomy. Such methods are characterized by minimal access to the reconstituted tissue and are anatomically deformed or divided from the normal oral pharynx or proximal gastroesophagus, It may be particularly useful where access via the esophagus is not possible. Such methods are also particularly useful when performing gastrotomy or gastrostomy for other medical reasons, such as enteral nutrition.

  As used herein, "hollow organ" means an organ of the patient's body, which refers to the organ's ability to receive and / or function as a conduit for liquid content. Depends on the primary function. Typically, a hollow organ is in fluid communication with another hollow organ and / or the exterior of the body. Most of the gastrointestinal tract and urogenital tract are classified as hollow internal organs. Such organs include the stomach, gall bladder, uterus, and bladder. Other hollow organs that also serve as fluid passages include the esophagus, small and large intestine, hepatic duct, gallbladder duct, common bile duct, pancreatic duct, heart, vein, artery, vagina, egg (ie Fallopian) duct, ureter , And the urethra.

  In the case of the stomach, which is a hollow organ, "liquid content" includes any of chewed food, swallowed liquid, chymes, gastric mucus, gastric acid, and other gastric secretions . In other cases, "liquid content" may include bodily fluids such as intestinal content, bile, exocrine pancreas, blood, and urine.

<Visualization by endoscope>
Endoscopic visualization may be used for all, part, or none of the procedure. According to one preferred embodiment of the present invention, the method is practiced in connection with visualizing at least the portion where tissue is engaged with an endoscope. Typically, as shown in FIG. 1, the first step of the method of the present invention includes the step of entering the endoscope 14 into the interior or lumen of the first hollow organ 10. Preferably, the endoscope 14 enters the interior of the first hollow organ 10 via the lumen 11 of the second hollow organ 12 which communicates with the first hollow organ 10 via a liquid. .

  Endoscopes are well known in the art. Typically, endoscopic instruments include lighting and visualization elements so that an operator can see inside the accessed body cavity. Also, in many cases, the endoscope will have at least one flow path suitable for the introduction and / or withdrawal of a liquid, gas or drug, and a needle, a grasper, a biopsy device, a brush, an electrode of an electric scalpel. Includes a work path suitable for containing remotely operated surgical instruments such as Acceptable visualization elements include fiberoptic-assisteddirect visualization, television array, and video array endoscopes. The endoscope 14 can be introduced into the lumen 13 of the first hollow organ as at least one aspect of the procedure and can be removed as at least one aspect of the procedure. Thus, endoscope 14 may be introduced, removed, and re-introduced to any one of the steps of the method of the present invention, or a combination thereof.

  An endoscope is a separate device from any other device used in performing the methods of the present invention. Alternatively, the endoscope cooperates with at least one other instrument used in the practice of the present invention, for example, the at least one instrument cooperates with the endoscope. Position. In other embodiments, the endoscope is incorporated into a tissue engaging device, at least a portion of a tissue engaging device, or a portion of a combined tissue engaging device and tissue anchoring device.

  As shown below, current flexible endoscopes may not be sufficiently rigid when bent to function as a working platform for performing manipulations on gastric tissue. Procedures such as pushing, pulling, and palpating left and right performed near the opening of the esophagus into the stomach require mechanical leverage, but in this case, a warped gastroscope usually has sufficient fulcrum. Can not be. When performing such operations in the stomach, an endoscope may be used with a specially constructed instrument as shown below to view the inside of the stomach. If a rigid endoscope is applied, the procedure can be performed without using any such specially structured instruments.

  In another embodiment of the invention, the method is performed at least in part with endoscopic visualization of the engaged tissue. Methods of visualization without an endoscope include techniques well known in the art, such as fluoroscopy with or without the use of appropriate x-ray contrast agents, and ultrasound diagnostics. It is not limited. In some embodiments, this procedure can be performed without performing any endoscope visualization.

<Engagement>
As shown in FIG. 2, the first step in this aspect of the invention is to engage a selected portion of the inner surface 16 of the first hollow organ 10.

  As used herein, the term "engagement" refers to reversibly penetrating, grasping, pinching (with forceps), in a mechanical manner to establish a physical connection with tissue, The act of holding, holding, tightening, aspirating, or contacting tissue. In certain preferred embodiments of the present invention, the engagement of the tissue is reversible and essentially atraumatic.

  For the purposes of the present invention, an endoscopic tissue engaging device has a proximal end and a distal end interconnected by an elongate portion of appropriate length and stiffness so that an operator It is believed that the distal end of the tissue engaging device of the endoscope can be remotely controlled into the body cavity by contacting and adjusting the proximal end of the tissue engaging device. Further, the operator of the tissue engaging device of the endoscope may operate one feature of an adjustment mechanism operably connected to the tissue engaging element located at the proximal end and the distal end. It is contemplated that a tissue engaging device located at the distal end can be moved.

  In some embodiments, the tissue engaging device may be a separate and separate instrument. In other embodiments, the tissue engaging device may be used in combination with another endoscopic instrument. In yet another embodiment, the tissue engaging device may be a component of a combined endoscopic instrument. In a preferred embodiment, the tissue engaging device is an element of an endoscopic instrument and also incorporates a tissue fixation device (see below).

  As used herein, "engaged portion" is intended to mean a piece of tissue that has actually been engaged by the device used to engage the tissue.

  In a preferred embodiment, the engaged portion simply includes the inner lining of the first hollow organ 10. For example, the engaged portion may include only mucus in the stomach. In other embodiments, the engaged portion can include the inner lining of the first hollow organ 10 and at least one additional tissue layer. Referring again to the stomach, the reconstituted portion includes the mucus of the muscle wall and at least one layer thereof, including the entire layer of the stomach wall.

  In certain preferred embodiments, the tissue engagement device engages tissue reversibly and essentially atraumatically. The method of tissue engagement of such an embodiment is not only effective in performing the next step of the method of the present application, but also the tissue engaged so as to slightly or completely break the intact tissue. Can be opened.

  For example, in the most preferred embodiment, the tissue engaging device includes a novel corkscrew-type element as described below. The tip of this helical corkscrew element penetrates to engage the tissue, but when the helix is removed by removing the corkscrew from the tissue, the penetration leaves one discontinuous place, but the tissue is The very soft tissue lining of the stomach closes off naturally, much like a hole made through a hypodermic needle.

  In yet another embodiment, the tissue engaging device is a known forceps device. In this technique, alligator forceps for endoscopes (see FIG. 2), forked jaw grasping forceps, rat tooth grasping forceps, three-prong grasping forceps, tripod forceps Examples of suitable endoscopic forceps devices such as (tripod grasping forceps), fenestrated cup forceps, and ellipsoid fenestrated forceps are well known, but are not limited to these. Not something. As used herein, each such endoscopic forceps device is believed to engage only a portion of the tissue. That is, all tissue in contact with the various jaws of a forceps device is considered a portion of the engaged tissue.

  In another preferred embodiment, the tissue engaging device is a novel suction device as described below. The tissue is engaged when contacted by suction and is atraumatically released when suction is stopped at a location other than where the tissue is engaged.

  According to the foregoing embodiment, the tissue engaging device engages tissue to twist, push, or contract tissue in a left-right procedure. Further, in another embodiment, the tissue engaging device may be, for example, such that the end of at least one leg of the surgical stapler is pointed. According to this embodiment, the tissue engaging device can engage the tissue not for contracting the tissue but for twisting or pushing the tissue left and right.

  In a preferred embodiment, the tissue engaging device may be incorporated into a tissue manipulation device. In this embodiment, the elongate portion of the tissue engaging device is further structured such that manipulation of the tissue can be atraumatically engaged, aspirated or penetrated as described above. As shown below, in the most preferred embodiment, a novel single instrument incorporating both a tissue engaging device and a tissue manipulating device independently engages tissue at two or more locations and tertiary to each other. The structure is such that two or more locations of the tissue can be operated in any direction in the original space. Typically, two or more independent points of tissue engagement are at least 1 cm apart before tissue engagement.

  In a preferred embodiment, the tissue engaging device 18 is advanced, preferably through the lumen 11 of the second hollow organ 12 to the lumen of the first hollow organ 10. In FIG. 2, the first hollow organ 10 is shown as a stomach, and the second hollow organ 12 is shown as an esophagus communicating with the hollow organ 10 via fluid. FIG. 2 shows a state in which the distal end 17 of the endoscope 14 and the distal end of the tissue engaging device 18 are in a predetermined position after entering the lumen 13 of the organ 10 through the lumen 11 of the organ 12. Indicates. The relevant portion of the inner surface 16 of the first hollow organ 10 is shown as being engaged by the tissue engaging device 18 of the endoscope 14 below.

  In one embodiment, as schematically illustrated in FIG. 2, in a preferred embodiment, engagement is achieved by engaging the tissue using a bifurcated forceps device 18. The device 18 has opposing jaws 15 and 19 with teeth 23 and the like. Sufficient engagement to maintain a physical connection with the tissue engaging portion when a rotational, pushing, or contracting force that deforms the tissue is applied to the tissue engaging portion by the tissue engaging device. A resultant force is required, while at the same time a sufficient force distribution is ensured that no penetration, tearing or cutting of the surface of the engagement part occurs.

  In a preferred embodiment of the present invention, at least two other points are simultaneously engaged in this engagement operation. The effect is to apply at least two tissue engaging devices, such as two separate endoscopic forceps devices, or a single tissue engaging device designed to simultaneously engage tissue at different locations. Achieved by The latter type of device is shown below.

  After engaging the tissue, the engaged portion must be released to remove the tissue engaging device from the hollow organ of the patient. Typically, the engaged portion relates to the reconstructed portion. That is, typically, in some aspects, such as where the reconstituted tissue is at a base, tip, or intermediate position relative to the reconstituted portion, the tissue engagement device may be used during the reconstitution process. Make up the tissue that is actually engaged.

<Operation>
As shown in FIG. 3, in the next step of the present invention, the engaged portion of the inner surface 16 of the first hollow organ 10 is manipulated to reconstitute at least a portion of the first hollow organ 10. . The inner surface 16 of the first hollow organ 10 is manipulated by a device 18 to form a reconstructed part 20. In this operating step, the device 18 pushes, pulls, twists, rolls, wraps, wrinkles, or otherwise pushes the tissue into the engaged portion of the inner surface 16. Physical forces are applied that are effective to displace the tissue from the structure before such forces were applied. In a preferred embodiment, the tissue that is continuous in close proximity to the actually engaged portion will have at least some deformation force in proportion to the magnitude and direction of the force applied to the engaged portion. From the original structure. Manipulation of the engaged tissue may be performed to indent, bulge, or a combination of invagination and bulge of at least the inner layer 16 of the first hollow organ 10.

  In one embodiment of this aspect of the invention, manipulation of the engaged portion of the inner layer 16 of the first hollow organ 10 includes traction or torsional force to form a reconstructed portion 20 that is an invaginated portion. Is achieved by adding Traction is linear and is achieved by pulling or the like. Alternatively, the traction force is non-linear and is achieved, for example, by winding the engaged tissue into a spool.

  As used herein, "invaginated portion" or "invaginated" means a portion of tissue that has been moved in a lumen direction of a hollow organ as a result of engagement and manipulation. The particular shape formed by the invaginated part is the geometry of the engaged part, the anatomy of the engaged part, the plasticity of the engaged organ fragment, and the applied force. Depends on factors such as the direction and size of

  An example of forming a depressed portion in the shape of a flap or a fold is shown in FIGS. FIG. 4 shows a cross-sectional view of the stomach facing the esophageal opening 36 toward the stomach. FIG. 4 also shows the opening 31 of the duodenum toward the stomach 31. In FIG. 4, the inner surface 16 of the stomach 10 is engaged at the flank opening 36 of the esophagus toward the stomach, that is, at one of two portions 37 and 39 of the opening 36 of the esophagus toward the stomach. I have. The engaged tissue is then manipulated in the direction indicated by arrow 38, that is, in the direction that would normally traverse from engaged portion 37 and portion 39 toward esophageal opening 36 toward the stomach. FIG. 5 shows a generally rectangular valve 40 formed by the engagement and operating steps shown in FIG. The valve 40 is secured at a portion 35 which points in the direction of the mouth of the esophageal opening 36 towards or across the stomach with respect to the engagement portions 37 and 39. The esophageal opening 36 towards the stomach is at least partially covered by a rectangular valve 40. The two tissue fixation devices each penetrate at least two layers of the stomach wall. The two layers are the grooved layer or layers and at least the stomach lining 16 near the esophageal opening 36 towards the stomach. The size and strength of this groove depends on the position of the anchoring portion 35 relative to the position of the engagement portions 37 and 39 and the opening 36 of the esophagus towards the stomach.

  A method for forming an alternative valve configuration is shown in FIG. The inner surface 16 of the stomach 10 is engaged at a single portion 41 near the esophageal opening 36 toward the stomach. The engaged tissue is then manipulated in the direction indicated by arrow 38, i.e., transversely from the location of the engaged tissue 41 toward the esophageal opening 36 toward the stomach. FIG. 6 shows a triangular valve 50 formed by the engagement and operation steps shown. The esophageal opening 36 towards the stomach is covered at least in part by a rectangular valve 50. The groove 50 (valve) is fixed at a single position 51 that typically traverses the esophageal opening from the location of the tissue engaging portion 41 to the stomach 36. One tissue fixation device extends through at least two layers of the stomach wall. The two layers are the layer or layers forming the groove 50 and the lining 16 of the stomach wall near the esophageal opening 36 towards the stomach. The size and strength of this groove 50 depends on the position of the anchoring portion 51 relative to the position of the engagement portion 41 and the opening 36 of the esophagus towards the stomach.

  It should be noted that the rectangular and triangular shapes described above are very rough. Due to the plasticity of the tissue involved, it is believed that the actual configuration of the tissue achieved by such a method need not be limited to rectangles or triangles. However, it is useful to think in terms of such shape and structure for the purpose of conceptually describing this method used to achieve the desired functional effect, ie, suppression of backflow.

  Reconstructed portions 20 include, but are not limited to, valves, grooves, ridges (bulges), mounds, elongated ridges, entanglements ("jelly rolls"), tubes, papillae, or cones. It is possible to take a range of one arbitrary shape. The mechanism of fluidity of the formed tissue includes, for example, the size, shape, thickness, radius, location, and configuration of the associated tissue, the shape of the fastener or fasteners, and the fastener or fasteners. Depends on the arrangement of the ingredients.

  In certain embodiments, the indentations forming the reconstituted portion 20 take on a raised shape of tissue. As used herein, "tissue ridge" means tissue that has been gathered or overlaid with a base or apex that is related to the contour of the tissue where the ridge is occurring. The periphery of the base is irregularly shaped or substantially regular, for example, substantially elliptical, substantially circular, substantially triangular, or substantially rectangular. It is. When viewed from inside the hollow organ, the protuberance of the tissue looks like a mass, aggregate, or mastoid. Tissue hills that form tissue ridges can be distinguished from tissue valves or grooves in that they need not have distinct surfaces or sides that are clearly visible. When viewed from inside the hollow organ, the protuberance of the tissue is smooth, depressed, or grooved.

  According to one embodiment of this aspect of the invention, the manipulating may include bringing in an appendage at least two locations of the tissue independently engaged by the at least one tissue engaging device.

  According to yet another embodiment of this aspect of the invention, a combination of tissue invaginations is formed. Therefore, for example, the valve and the groove are formed in a combined state. Other embodiments include, but are not limited to, at least two valves, at least two ridges, at least two folds, one wrap and one ridge, and the like. Combinations of tissue invaginations are formed essentially simultaneously or sequentially.

  According to yet another embodiment of this aspect of the invention, manipulation of the engaged portion of the inner surface 16 of the first hollow organ 10 forms an outwardly directed protrusion of the first hollow organ from the inside. This is achieved by applying a guiding or pushing force (not shown). According to this method, the reconstructed portion 20 is a bulge, not an invaginator. The bulge, when viewed from the outside of the hollow organ, takes a shape including, but not limited to, a ridge, a mass, an aggregate, a valve, a groove, a tube, a corner, or a mastoid. Also, as seen from the outside of the hollow organ, the bulge of the tissue is smooth, concave or grooved. The periphery of the base is irregularly shaped or substantially regular, for example, substantially elliptical, substantially circular, substantially triangular, or substantially rectangular. It can be something. The method also contemplates forming a plurality of bulges, which bulges may be made simultaneously or sequentially. At least one bulge is combined with at least one inset.

  In some embodiments, the reconstituted portion 20 simply includes the inner lining of the first hollow organ 10. For example, the reconstituted portion 20 can include the mucosa in the stomach. In other embodiments, the reconstituted portion 20 can include the inner lining of the first hollow organ and at least one additional tissue layer. Referring again to the stomach, the reconstituted portion includes the mucus of the muscle wall and at least one layer thereof, including the entire layer of the stomach wall.

<Fixed>
After this operating step, the following steps may include a first hollowing step so that the effect of permanently maintaining the shape of the reconstructed part 20 is achieved, as shown in FIGS. A method for permanently fixing the reconstructed portion 20 of the organ 10 is included. The reconstructed portion 20 of the organ 10 is maintained in that the operating force applied to the engaged tissue portion via the tissue engaging device 18 is maintained under the control of the operator while the operator The distal effector end 21 of the illustrated tissue fixation device 22 is brought into contact with the reconstituted portion 20. The distal effector end 21 of the tissue fixation device 22 includes at least one biocompatible tissue fixation device 24 as described below and includes at least one biocompatible tissue fixation device 24. The structure is such that it is applied to the reconstructed portion 20. The tissue fixation device 22, together with the tissue engagement device 18, is advanced into the lumen 13 of the first hollow organ before or after its application. Thereafter, the tissue fixation device 22 operates to apply the at least one biocompatible tissue fixation device 24 to permanently fix or fix the shape of the reconstituted portion 20.

  As used herein, "permanently fix" means directly placing a biocompatible tissue fixation device that is effective to stabilize the tissue at the desired location. Preferably, the permanent fixation is achieved from inside the inner surface 13 of the first hollow organ 10. "Permanent" means a period of clinical effectiveness. This definition means that the operator intentionally and actively removes the tissue fixation device based on professional judgment. Where permanent fixation is achieved by applying at least one aspirable tissue fixation device, the present invention relates to a method in which such a device occurs in-situ while maintaining its original state or is capable of being aspirated. Taking into account the formation of tissue bonds resulting from the use of a tissue fixation device. By "permanent fixation" is meant that such tissue is effective in maintaining the configuration of the reconstituted tissue after aspiration by a suctionable tissue fixation device.

  According to a preferred embodiment of the present invention, fixing the invaginated portion of the hollow body organ in the new position preferably does not include tissue unrelated to the first hollow body organ. Accordingly, the method of the present invention preferably does not include securing the first hollow body organ to tissue of the second hollow body organ 12 that is in fluid communication with the first hollow body organ. In certain instances, where the first hollow body organ 10 is the stomach and the second hollow body organ 12 is the esophagus, according to this embodiment, the stomach tissue is only fixed to the stomach tissue. , Not fixed to the esophageal tissue.

  The tissue fixation device 24 of the present invention is a mechanical entity useful for fixing at least one particular form of tissue. The tissue fixation device 24 is placed or applied to the tissue by the tissue fixation means 22 configured to carry the tissue fixation device 24.

  For purposes of the present invention, the tissue fixation device 22 has a proximal end and a distal end 21 interconnected by an elongate portion of an appropriate length, which allows the operator to use the endoscope tissue fixation. It is believed that contacting and controlling the proximal end of the device 22 allows for remote control of the interior of the body cavity using the distal end 21 of the tissue fixation device 22 of the endoscope. Further, the operator of the endoscope tissue fixation device 22 operates at least one feature of an operating mechanism located at the proximal end and operably connected to an effector element located at the distal end 21. Could move the effector element located at the distal end 21. The effector element can be configured to transmit radio frequency (RF) to at least one tissue fixation device 24, tissue adhesive, or tissue in contact with the effector element.

  The tissue fixation device of some embodiments may itself be a separate instrument. In other embodiments, the tissue fixation device can be used in combination with another endoscopic instrument. Further, in another embodiment, the tissue fixation device can be a component of the endoscopic instrument combination. In a preferred embodiment, the tissue fixation device is a component of an endoscopic instrument that forms an instrument that also incorporates a tissue engaging device.

  In a preferred embodiment, tissue fixation device 24 is a biocompatible stapler and tissue fixation device 22 is an endoscopic surgical stapler. Examples of surgical staples as disclosed in U.S. Pat. Nos. 5,040,715 and 5,376,095 are well known in the art. The staple device may be of the pedestal or one-sided type. Biocompatible stapler needles are typically made from non-absorbable materials such as titanium or stainless steel, but the invention also incorporates other materials, such as absorbent materials. In an embodiment of the present invention, the tissue fixation device 24 may be a physically compatible clip, stud, rivet, two-part fastener, spiral fastener, T-suture, or the like. Examples are well known in the art. In a preferred embodiment, the tissue fixation device 24 is non-absorbable.

  In some embodiments, the tissue fixation device 24 extends only through the inner lining of the first hollow organ 10. This inner layer is, for example, a mucosal lining inside the stomach. Alternatively, the tissue fixation device 24 extends through both the inner layer of the first hollow organ 10 and at least another layer. The at least one further layer is, for example, a muscle layer of the stomach wall. The combination of the inner layer and at least one other layer constitutes either a layer of variable thickness or all layers. The fixing step of the present invention includes, for example, fixing the inner layer to a layer of variable thickness. This step also includes, for example, fixing the inner layers to all layers. In some alternatives, in this fixation step, the tissue fixation device may either (1) penetrate through a layer of variable thickness or (2) penetrate all layers, or penetrate through all two layers of the first hollow organ 10. I do. The latter fixation step, for example, fixes an incision in the whole layer, in which two or more distinct areas of the outer surface of the first hollow organ are juxtaposed (not shown).

  In still other embodiments, where one or more tissue fixation devices 24 are used, any number of tissue fixation devices 24 can be combined to penetrate any combination of layers. For example, a first tissue fixation device 24 that penetrates a layer of variable thickness may be used in combination with a second tissue fixation device that penetrates only the inner layer. In another example, a first tissue fixation device 24 that penetrates both the inner and non-constant thickness layers can be used in combination with a second tissue fixation device that penetrates the inner and all layers. Such and other possible combinations of tissue fixation devices used to secure combinations of tissue layers are intended to be covered by the present invention.

  9-13 illustrate various geometric patterns that can be used when the at least one tissue fixation device 24 is a biocompatible staple. If more than one tissue fixation device 24 is used, the tissue fixation devices 24 can be used sequentially or simultaneously. Examples of geometric patterns include one line (FIG. 9), three or more parallel lines (FIG. 10), three or more non-parallel lines such as a "T" shape (FIG. 11) and a cross, At least one polygon, such as a triangle (FIG. 12), at least one arc, such as three or more curves (FIG. 13), at least one circle. The purpose of this option is to spread the pressure created by securing to a larger area of tissue and provide a fail-safe condition, i.e., even if one of the tissue fixation devices fails, Forming and maintaining shapes and positions for optimal clinical effect by drilling multiple holes in the tissue while maintaining fixation and causing bleeding or migration of fiber cells.

  Achieving the desired reconstitution of the tissue requires three or more engagement, manipulation and fixation cycles of operation. For example, in certain instances, the desired size or shape that is expected to be effective may not be achieved with only one engagement, operation, and lock cycle. The method also releases the engaged portion of the first hollow organ 10 and selectively re-engages that portion or engages another portion, which is subsequently engaged. Operate the part and fix it permanently.

  The shape of the tissue of the portion 20 reconstructed by said fixation allows the normal flow to proceed from the second hollow organ 12 to the first hollow organ 10 while the first to the second hollow organ 12 May be effective in restricting the flow of the liquid content of the hollow organ 10. Examples of unwanted flow from one hollow organ to an adjacent second hollow organ include gastroesophageal reflux, reflux of urine from the bladder to the ureter, and reflux from one chamber to another in the heart. Blood flow due to atrial or ventricular septal defects.

  Permanently fixed and reconstituted portion 20 is preferably effective to restrict the flow of the liquid content of first hollow organ 10 to second hollow organ 12. The reconstituted portion may be a valve, which may prevent or restrict the passage of contents from organ 10 to organ 12. Preferably, this valve functions as a check valve. In a preferred embodiment of the present invention, the valve made to achieve this purpose is a flap valve. Examples of such valves that occur naturally in the human body include the aortic, mitral, pulmonary, and tricuspid valves of the heart, the gastroesophageal valve, the ileocecal valve, the epiglottis valve, and the intravenous valve. is there. Also, it can be seen that the normal flap valve is present at the junction between the bladder and the ureter. Other types of valves made by the method of the present invention include papillary valves and multi-leafed valves.

  In the case of the stomach, it is most desirable that the valve that effectively interconnects the stomach and the esophagus function effectively to prevent the flow of stomach contents into the esophagus under normal conditions. This ideal valve allows, under the right conditions, the release of gas from the stomach into the esophagus, the regurgitation of gastric contents into the esophagus and the intervening suction of gastric contents. In a normal human, the gastroesophageal valve achieves this functional distinction to a desired degree.

  The desired effect resulting from the fixed and reconstructed portion 20 includes the effect of reducing the frequency of unwanted backflow, reducing the amount of unwanted backflow or backflow, and reducing unwanted backflow or backflow. This has the effect of suppressing symptoms caused by flow or reflux, and the effect of increasing the pressure generated between the first hollow organ 10 and the second hollow organ 12. Such desired effects are measured in relation to similar conditions such as lying down, inversion, coughing, sneezing, etc., before the steps of reconstruction and fixation are combined. Both of these effects are due to the ability of the fixed reconstituted portion 20 to block fluid flow from the first hollow organ 10 to the second hollow organ 12 near the esophageal opening 36 toward the stomach. This is accomplished at a junction such as the gastroesophageal junction (GEJ).

  In the preferred embodiment, the fixed and reconstructed portion 20 reduces the frequency of unwanted backflow by at least 50%. Most preferably, the frequency of unwanted backflow episodes is reduced by about 100%.

  In another preferred embodiment, the fixed and reconstituted portion 20 is effective to enhance the capacity of the GEJ. As used herein, "GEJ receptivity" refers to a GEJ that completely blocks the flow of stomach contents to the esophagus with normal passage of food from the esophagus to the stomach. Means the ability. If the capacity of the GEJ is sufficient, the flow of gastric contents to the esophagus will be completely obstructed, while allowing normal passage of food from the esophagus to the stomach.

  As used herein, the term "reflux symptom" refers to the backflow of distal hollow organ contents to a proximal hollow organ that is in fluid communication with a first hollow organ. Due to an objective clinical manifestation other than the patient's subjective experience. In one preferred embodiment, the reflux condition is associated with gastroesophageal reflux.

  As used herein, "effective in reducing the symptoms of reflux" refers to substantially reducing the frequency, frequency, and / or severity of symptoms resulting from accidental or chronic reflux. Means to reduce to In a preferred embodiment, the frequency of reflux symptoms is reduced by at least 50%. In another embodiment, the severity of the reflux condition is reduced by at least 50%. In yet another embodiment, the number of reflux symptoms is reduced to at least one.

  The fixed and reconstructed portion 20 reduces the yield pressure at the connection connecting the first hollow organ 10 to the second hollow organ 12, such as GEJ, near the esophageal opening 36 toward the stomach. It may be effective to raise. As used herein, “yield pressure” means the internal pressure of the first hollow organ 10 greater than the pressure gradient, or the difference between the first hollow organ 10 and the second hollow organ. Means the pressure maintained between. In other words, the yield pressure is a change in pressure sufficient to cause the contents of the first hollow organ 10 to flow into the lumen 11 of the second hollow organ 12. Before reflux occurs when gas or liquid is injected into the stomach, as is added to the yield pressure in GEJ, the yield pressure that reaches the stomach is the maximum pressure, less the resting gastric pressure. is there. Typically, the yield pressure at GEJ is in the range of 7-15 mmHg of healthy humans (McGouran RCM et al., Gut 29: 275-8 in 1988; Ismail T, et al., Br J Surg 82: 943-7, 1988). Yes, gastroesophageal reflux disease of GERD patients below 5 mmHg (the above values of McGouran RCM et al., 1988, Gt 330: 1309-12 of McGouran RCM et al., 1989; the above values of Ismail T, et al., 1995). Is greater than 14 mmHg of GERD patients who responded to the operation (the above values of McGouran RCM et al., 1988; the above values of Ismail T, et al., 1995).

  As used herein, "effective to increase the yield pressure" refers to a case where the higher the yield pressure before the treatment, the more objectively the increase in pressure can be detected when measured. In a preferred embodiment of the invention, the yield pressure is increased to at least 75% of normal. The practice of the present invention may include objectively measuring the rise in yield pressure, but this is not required.

  To demonstrate, by means of examples, the principle of the formation of ridges that impede gastroesophageal reflux, a bench test was performed on the stomach of an isolated pig and its associated esophagus. The duodenum was clamped, a larger bend in the stomach was cut, and the stomach was turned over and filled with water. It was confirmed that gravity caused water to flow from the stomach to the esophagus in a steady stream. A bump was formed in the stomach wall within 1 inch of the esophageal opening to the stomach. The ridge was fixed in place using a staple. The stomach was then refilled with water. After this procedure, it was confirmed that water did not flow from the stomach into the esophagus by gravity. A イ ン チ inch diameter tube was passed through the esophagus and the esophagus opening to the stomach, both before and after making the ridge, so that the ridge did not approach the lumen of the esophageal opening toward the stomach.

  To demonstrate in vitro the effect of creating a bump on the yield pressure in the stomach, pigs were subjected to general anesthesia and the stomach was opened by abdominal incision. Two small holes were made in the stomach, one of which was fitted with a tube into which saline was poured, and the other with a pressure monitoring catheter. A purse string suture was applied to each of the incisions to secure the tubing, leaking and sealing the stomach tissue to the contents. After clamping the pylorus, saline was poured into the stomach via an injection tube until the stomach was full. The stomach was then manually squeezed and the maximum pressure was observed on a device attached to a pressure monitoring catheter. The average maximum pressure measured was 32 mmHg.

  The contents of the stomach were evacuated and the stomach wall was dissected so that the device could be placed in the stomach. A ridge was created within one inch of the esophageal opening to the stomach and secured in place using a staple. The incision in the stomach was sealed with suture and the stomach was filled with saline. The stomach was then manually squeezed again and the maximum pressure was measured as described above. The average maximum yield pressure after the formation of the ridge was 57 mmHg. Thus, the yield pressure has risen to about 80% above the norm.

<B. Endoscopic treatment method for reconstructing tissue in stomach for GERD treatment>
In another aspect, the present invention relates to an endoscopic treatment method for reconstituting tissue in the stomach for GERD treatment. This method of treatment involves the formation of a flap valve that provides an effective barrier to gastric fluid content as the gastric fluid content enters the esophagus, while the bumps in the gastric tissue cover the esophageal opening. It is based on the findings of the condition. Effective flap valve acts as a non-return valve, meaning that swallowed liquids and solids pass freely from the esophagus to the stomach, while allowing gas to escape properly from the stomach to the esophagus during burping But do not pass in the opposite direction.

  As used herein, a "flap valve" has an opening and at least two sealing surfaces and, when properly positioned, effectively approaches the opening. In one preferred embodiment, at least one of the sealing surfaces is provided by a movable valve or a rigid part of the tissue. When this surface is in close proximity, the sealing surface of the valve will engage either the other valve or valve seat so as to form an effective closure or seal around the opening. And at least one other sealing surface.

  In certain embodiments, the receptive flap valve functions as a check valve, directing the flow within the valve in one direction and restricting the flow within the valve from flowing in the opposite direction. Is what you do. As applied to the stomach, an acceptable flap valve allows the swallowed material to flow freely from the esophagus 12 toward the stomach 10 and allows the liquid contents to flow freely from the stomach 10 to the esophagus 12. To prevent For a healthy human, such a flap valve would open so that the swallowed bolus would pass from the esophagus 12 to the stomach 10, but for an unhealthy human, the flap valve would remain closed. , Preventing backflow of liquid contents from the stomach 10 to the esophagus 12.

  FIG. 14 shows a normal gastroesophageal flap valve 70 in the stomach 10 having an inner surface 16. Here, the flap 67 and the valve seat 69 have the required sealing surfaces. In this view, taken from a perspective view of the interior of the stomach facing the stomach opening 36 towards the stomach, the bulge 67 of the valve 70 is on the right and the esophageal opening 36 towards the stomach is abundant. The seat 69 is under a ridge that covers the left side. As used herein with respect to the stomach 10, "flap valve 70" refers to the stomach, even when the flap valve within the stomach 10 is posterior or lower than the esophageal opening 36 toward the stomach. It should be considered as "covering" the esophageal opening 36.

  Two factors can render flap valve 70 incapable. One factor is when the tissue 67 does not have enough ridges. In the absence of enough ridges 67 to form a seal with at least one other sealing surface 69, it is not possible to effectively close the esophageal opening 36 towards the stomach. . The ridge 67 may be very small or may simply not be present. The second factor is whether the sealing surface is in an effective position. Even when sufficient ridges 67 are present, it is not possible to close the esophageal opening 36 into the stomach if the sealing surface is not properly positioned. As used herein, a sealing surface is properly "placed" when its surfaces form an effective barrier to backflow by contact with each other.

  In clinical applications, the presence or visibility of the gastroesophageal flap valve and the juxtaposition of the sealing surfaces are typically assessed by endoscopic visualization. The inspection endoscope is warped to see the opening of the esophagus towards the stomach. The axis of the endoscope near the warped portion traverses the opening, thereby visualizing the valve and sealing surface in contact with the axis of the endoscope. By way of example, Hill et al. Have developed the following rating system to explain the flap valve appearance as observed. Grade I refers to a condition in which tissue extending along the endoscope axis has prominent wrinkles and is in close proximity to the endoscope throughout all stages of breathing. Grade II refers to a condition in which the wrinkles of the tissue extending along the axis of the endoscope are small, and temporarily open and close around the endoscope during breathing. Grade III refers to a state in which wrinkles are present, but no protrusion or close contact with the endoscope is observed. Grade IV refers to a state in which no wrinkles exist and an opening is opened around the endoscope. This grade is described in Hill LD et al., 1996, Gastrointest Endosc 44: 541-7. Obviously, according to the criteria provided by this general method, the sealing surfaces are classified as juxtaposed in grade I. In this way, although not obvious, if there is continuous contact between the entire circumference of the endoscope axis and the tissue of the connection between the esophagus and the stomach, with or without tissue wrinkles, The sealing surfaces are juxtaposed in any state.

  Three methods are described below based on the state of the gastroesophageal flap valve using an endoscope (Table 1). The first method is for clinical conditions where there is sufficient elevation but the sealing surface is not juxtaposed. The method includes tightening a flap valve that is present with the sealing surface and the ridge close together. The second method is for clinical situations where there are not enough bumps but the sealing surfaces are side by side. The method includes creating a ridge in the absence of a ridge, or, alternatively, increasing an existing ridge that is large enough to cover an esophageal opening to the stomach. In. The third method is for clinical conditions where there is no sufficient elevation and no juxtaposition of the sealing surface. The method includes creating or increasing a ridge and bringing the ridge or sealing surface into close proximity.

  In a preferred embodiment of the invention, the three methods are performed, at least in part, for at least part of one or more steps of the procedure, with endoscope visualization of gastric tissue. Suitable instruments for performing this method are described in another section below. Other aspects of each of the three methods will be described in detail.

<Sufficient bumps but improperly juxtaposed sealing surfaces>
<Forming ridges or tightening existing flap valves>
As shown in FIGS. 14 and 15, to treat a condition where there is sufficient elevation but the sealing surfaces are improperly juxtaposed, optionally include at least one lower layer of the stomach wall 34 The inner surface 16 of the stomach 10 engages at two or more separate portions 73 and 75. As shown in FIG. 15, the engaging portion 73 and the engaging portion 75 are connected to the stomach 36 in the vicinity of the esophageal opening 36 toward the stomach, facing the raised portion 67 present in the flap valve 70 of the stomach esophagus. It is placed on the opening side of the esophagus. As shown in FIG. 15, the locations of the engaging portions 73 and 75 are not limited. As shown in FIG. 15, the location of the engagement portions 73 and 75 and the location of the raised portion 67 are related by the placement of the esophageal opening 36 on the opposite side of the esophagus opening 36 toward the stomach. Therefore, in clinical practice, the location of the engaging portion 73 and the engaging portion 75 depends on the location of the raised portion 67, and thus the location of the engaging portion 73 and the engaging portion 75 and the location of the raised portion 67. Is different from that shown in FIG. 15 by a rotation of 180 ° around the esophageal opening 36 towards the stomach. Next, the positions of the engaging portion 73 and the engaging portion 75 are moved in the directions of the arrows shown in FIG. 15 to form a bulge or small hill 72 of tissue. This operation can be easily performed by an operation including squeezing. The tissue bulge 72 thus created can shift the sealing surface of the valve seat 69 toward the bulge 67. In such manipulated stomach tissue, at least one tissue fixation device is used to secure at the tissue fixation point 77 to engage the shape of the tissue bulge 72 in the manner described above. Thus, the thus permanently established tissue bulge 72 moves the sealing surface of the valve seat 69 in the direction of the sealing surface of the existing raised portion 67 to effectively engage the receptive flap valve. To be reconfigured.

  As shown in FIG. 16, in another preferred embodiment of the method of the present invention, the gastric tissue is opened into the stomach towards the stomach on the same side as the ridge 67 where the gastroesophageal flap valve 70 is located. On the part 36, it is engaged at two points 77 and 79 near the opening 36 of the esophagus towards the stomach. As shown in FIG. 16, the locations of the engagement portions 77 and 79 are not limited. As shown in FIG. 16, the location of the engagement portions 77 and 79 and the location of the ridge 67 are related by an arrangement on the same side as the esophageal opening 36 toward the stomach. Therefore, when clinically performed, the location of the engaging portion 77 and the engaging portion 79 depends on the location of the raised portion 67, and thus the location of the engaging portion 77 and the engaging portion 79 and the location of the raised portion 67. Is different from that shown in FIG. 16 by a rotation of 180 ° around the esophageal opening 36 towards the stomach. The stomach tissues engaged by the engaging portions 77 and 79 in this manner are operated so as to be substantially close to each other. Such an operation forms a tissue bulge 81 which moves the sealing surface provided by the bulge 67 in the direction of the opposing sealing surface 69 of the esophageal opening 36 towards the stomach. Let it. This permanently established tissue bulge 81 moves the sealing surface provided by the existing raised portion 67 in the direction of the sealing surface 69 on the opposite side of the esophageal opening 36 towards the stomach. This effectively reconfigures the receptive flap valve.

  In yet another embodiment of the present method for treating this disease, as shown in FIG. 17, gastric tissue is engaged with two or more pairs of independent tissue engaging portions. However, near the esophageal opening 36 toward the stomach, one of the pairs is defined by portions 85 and 87, and the other pair is defined by portions 89 and 91. Preferably, this pair of locations is located around the esophageal opening 36 toward the stomach as follows. That is, the portion 85 and the portion 87 are on the same side as the ridge 67, and the portion 89 and the portion 91 are on the side of the esophagus opening 36 toward the stomach facing the ridge 67. Therefore, in clinical practice, the location of the engagement portions 85, 87, 89, and 91 and the location of the elevation 67 are: It differs from that shown in FIG. 17 only by a 180 ° rotation around the esophageal opening 36 towards the stomach. The pair of portions 85 and 87 may be engaged in one step of the method, and the pair of portions 89 and 91 may be engaged in another step of the method. Both the pair of portions 85 and 87 and the pair of portions 89 and 91 are operated separately in the direction of arrow 78 to bring the portions 89 and 91 substantially close, except that Keep in close proximity. At least two tissue fixation devices are used against the gastric tissue of fixation 93 and fixation 95 in the manner described above to maintain the configuration achieved by this manipulating step. The pair of portions 85 and 87 may be fixed in one step of the method, and the pair of portions 89 and 91 may be fixed in another step of the method. The fixing step of FIG. 17 includes manipulating the manipulated tissue fragments with each other (eg, portion 85 into portion 87 and portion 89 into portion 91), or manipulating the independently manipulated fragments. The method may include a step of fixing to a part that has not been performed. Unlike the previous embodiments, this embodiment of the method does not necessarily create a tissue bulge. However, this embodiment of the method also provides for juxtaposition of the sealing surface provided by the sufficient ridge 67 present and the sealing surface 69 on the side opposite the esophageal opening 36 toward the stomach. Effectively reconfigure a capable flap valve.

<There is not enough flap, but the sealing surfaces are properly juxtaposed>
<Formation or increase of flap>
There is not enough flap, but the method described previously for FIGS. 20 and 21 is used to repair a properly juxtaposed sealing surface. Inner stomach wall tissue 16 optionally includes at least one basal layer of stomach wall 34 and is engaged at points 37 and 39 near esophageal opening 36 to the stomach. Each point 37 and so that the subsequent manipulations, as well as the fixation step, result in a flap of sufficient area to cover properly positioned gastric tissue and at least one significant portion of the esophageal opening 36 to the stomach. 39 must be located relative to the esophageal opening 36 leading to the stomach. The gastric tissue engaged at each point 37 and 39 is manipulated in the direction of arrow 38 (eg, toward esophageal opening 36 into the stomach). The operation of the two points 37 and 39 is shown in FIG. 4 and results in the formation or enlargement of a substantially rectangular flap 40 as shown in FIG. The gastric tissue is then fixed at the two fixing points 35 in the manner described above, and the rectangular shape of the flap 40 is substantially maintained. The size and tightness of the flap 46 over the esophageal opening 36 into the stomach will vary based on the location of the fixation point 35.

  In an alternative embodiment of this method of the invention, as shown in FIG. The triangular flap 50 forms and grows. The substantially triangular flap 50 is secured by a single tissue fixation device to gastric tissue at the tissue fixation point 51 in the manner described above.

  FIGS. 18-20 show another alternative embodiment of the method of the present invention for remedying the problem of not having sufficient flaps, but having the sealing surfaces properly juxtaposed. The inner wall tissue 16 is engaged at points 37 and 39 near or on one side of the esophageal opening 36 to the stomach and is invaginated to form a rectangular invaginated flap 60 (FIG. 18 and FIG. 19). In FIG. 18, the flap 60 is approaching from outside the paper surface. After the engagement and manipulation steps shown in FIGS. 18 and 20, the substantially rectangular flap 60 is secured to the bottom of the flap 60 by one or more tissue fixation devices 24. In the second step, shown in FIG. 19, the free edge of the resulting flap 60 is pulled toward the opposing surface of the esophageal opening 36 leading to the stomach and positioned to cover the esophageal opening 36 leading to the stomach. Thus, at one or more points 61 facing the esophageal opening 36 leading to the stomach from the fixed bottom of the flap 60, it is secured against gastric tissue at this location. The two tissue fixation devices each pass through at least two gastric wall layers (the layer forming the free edge of the flap 60 and at least the stomach lining 16 near the esophageal opening 36 to the stomach). The size and tightness of the flap depends on the location of the anchoring point 61 with respect to the bottom of the flap 60 and the esophageal opening 36 that leads to the stomach.

<There is not enough flap, but the sealing surfaces are properly juxtaposed>
<Making or increasing flaps combined with bringing sealing surfaces together>
In order to repair the situation where sufficient flaps of tissue are no longer present and the sealing surfaces are not juxtaposed, a pair of bulges are created and fixed in the stomach by the technique described below with respect to FIGS. It folds.

  As shown in FIG. 20, the endoscopic tissue engagement and tissue fixation device 80 is guided through the lumen 11 of the esophagus 12 to the lumen 13 of the stomach 10. The distal end of the tissue engagement and fixation device 80 includes a pair of tissue engagement elements 82 and a pair of tissue fixation elements 84 disposed on rotatable and positionable arms 86, respectively. The two tissue fixation device elements 84 can be two aspects of a single device, for example, one element can be a fixed end for the other element. Alternatively, the two tissue fixation device elements 84 can be uniquely two independent tissue fixation devices (eg, a one-sided stapler). The movement of the two movable arms 86 can be dependently interlocked or independent of each other. The operator selects two surfaces adjacent the esophageal opening 36 to the stomach on the inner stomach wall 16 for engagement by two tissue engaging elements 82.

  FIG. 21 shows that once engaged on both sides, the operator then vibrates the arm 86 of the endoscopic tissue engaging device / tissue anchor 80 combination, thereby straddling the GEJ or distal esophagus. 2 shows a method by which a pair of bulges 100 can be formed. The two bulges 100 are then juxtaposed and the two fixator elements 84 deploy at least one tissue fixation device to secure one engaged portion 100 to the other.

  FIG. 22 is an external view of the stomach 10 (without the endoscopic tissue engaging device / tissue anchoring device 80 combination), showing the external surface counterparts 97 and 99, and the arrow 88 for tissue manipulation purposes. Is shown.

  As noted above, immobilization involves placement of at least one tissue fixation device 24 from the lumen 13 of the stomach 10 via at least one sufficiently thick layer of the stomach wall. FIG. 23 shows an exterior view of the stomach 10 after deployment of the tissue fixation device 24 connected to the apposition surface of the bulge 100 to form a partial gastric wrap. Tissue fixation device 24 is drawn in dashed lines to indicate that it is not visible from outside the stomach.

  In one embodiment of the method, at least one of the bulges 100 contacts exogenous tissue structures to the stomach 10 as shown in FIGS. 20-22 and 24 and described in detail below. And fixed. The extrinsic tissue structure for the stomach 10 is preferably the surface of the diaphragm 110. In a particularly preferred embodiment, the surface of the diaphragm 110 is interposed between the bulges 100 and simultaneously the bulges 100 are fixed to each other by the fixing device 24 so that the inserted surface of the diaphragm 110 is bulged 100 Fixed to By securing the portion of the stomach 10 near the GEJ to the extrinsic, relatively mobile tissue structure to the stomach 10, an effective barrier against reflux is created or guaranteed. Hill LD et al. (1990) Gastroenterol Clin North Am 19: 745-75.

<C. Endoscopic method to cure hiatal hernia>
In another aspect, the invention is directed to an endoscopic method for treating hiatal hernia. The method includes engaging one side of the stomach from the inside, relieving the hernia (eg, manipulating the engaged portion of the stomach to reposition the hernia below the diaphragm), Manipulating the gastric portion engaged to contact the gastric portion with the surface of the extrinsic tissue structure to the stomach, and securing the gastric portion to the surface of the extrinsic tissue structure to the stomach Including that.

  According to a preferred embodiment of this aspect of the invention, the tissue exogenous to the stomach is the surface of the diaphragm 110. In a most preferred embodiment, the exogenous tissue to the stomach is the median arcuate ligament. In other preferred embodiments, the exogenous tissue to the stomach can include the right leg, the left leg, the aortic fascia, the hepatogastric ligament, the omental, or the omental.

  The preferred method includes a bulge very similar to the method shown in FIGS. 20-23 and has the additional feature of engaging and securing the surface of the exogenous tissue to the stomach between the bulges 100.

  Preferably, but not necessarily, as shown in FIGS. 20-22 and FIG. 24, the face of the diaphragm 110 is sandwiched and fixed by a tissue fixation device 24 between the two bulges of the stomach wall. A preferred aspect of the diaphragm 110 is the portion of the median arcuate ligament 112. The method anchors the stomach 10 to the diaphragm 110, forms the flap element of the flap valve at the esophageal opening 36 to the stomach, and brings the sealing surfaces together, eg, the opening of the esophageal opening 36 to the stomach. Achieving the combined effect of transferring tissue at the base of the directional flap.

  An advantage with tissue exogenous to the stomach lies in its ability to limit the freedom of movement of at least a fixed portion of the stomach relative to other organs or tissues. The importance of limiting such movement is well recognized in surgical treatment of GERD. Hill LD 1989, J Thorac Cardiovasc Surg 98: 1-10. The classic Hill gastrostomy procedure, which is a public procedure, involves eliminating or reducing the mobility of a slip-hiatal hernia by anchoring the GEJ to the median arcuate ligament of the diaphragm.

  As seen in other aspects of the invention, endoscopic visualization may be used for all or part of the method.

  In a preferred embodiment, the at least one tissue fixation device 24 continuously penetrates the stomach 10 of sufficient thickness, the captured surface of the diaphragm 110, and the stomach 10 continuously. In another embodiment, the at least one tissue fixation device 24 extends completely through one full thickness one surface of the stomach 10 and through the captured surface of the diaphragm 110 and removes the open surface of the stomach 10. Partially penetrates. Alternatively, the immobilization comprises: (1) applying at least one immobilization device 24 through one full thickness surface of the stomach 10 to at least a portion of the captured surface of the diaphragm 110; This is done by applying at least one tissue anchoring device 101 through the full thickness second surface of the stomach 10 to at least a portion of the captured surface of the diaphragm 110. Similarly, full and partial thickness two-sided immobilization may be used.

  According to another embodiment of the present method of the invention, the surfaces of the stomach 10 and the extrinsic tissue structure 110 are juxtaposed by engagement and invagination of portions of the inner surface of the stomach 10. The stomach 10 and the extrinsic tissue structure 110 are then both immobilized by application of at least one fixation device 24 from the stomach lumen 13 to penetrate both the stomach and the at least some thickness of the exogenous tissue structure. I do.

  In another embodiment of the present method of the invention, the stomach 10 and the exogenous tissue structure 110 can of course be in a desired juxtaposition. In such an application, no engagement and manipulation steps are required. The gastric and extrinsic tissue structures are then both immobilized by the application of at least one fixation device 24 from the lumen 13 of the stomach 10 and penetrate both the stomach and at least some thickness of the exogenous tissue structures. .

<D. Instrument and device for endoscopically reconstructing tissue in a medium air tube>
In another aspect, the present invention relates to a novel device useful for reconstituting tissue in a medium air duct according to the method of the present invention. Such an instrument may incorporate at least two of a tissue engaging device, a tissue manipulation device, a tissue fixation device, and an autopsy endoscope. In a preferred embodiment, as described below, the present invention provides a single instrument that combines a tissue engaging device, a tissue manipulation device, and a tissue fixation device. A unique feature of this combination device is that the device can manipulate more than one point in any desired direction in three-dimensional space.

  An example of a preferred combination device 200 incorporating a tissue engaging device and a tissue manipulation device will be described with reference to FIGS. 25, 26, 30, and 32 to 36.

  The device 200 includes an inner tube 280, a center outer tube 290, a pair of opposing gripping arms 210, a gripping arm yoke 220, a pair of independent small grips 250, a segmentable stapler arm 230, a stapler arm yoke 240, and a stapler cartridge. 260 and a stapler fixed end 270. The device 200 may be constructed such that it can be sterilized by any method known in the art (eg, steam autoclave, gamma irradiation, and gas sterilization). The gripping arm 210 is attached to the gripping yoke 220, and the gripping yoke 220 is attached to the outer tube 290 by the connecting portion 222 that can be sequentially segmented. Thus, the gripping arm 210 can be opened and closed for gripping and pivot about 180 ° as a building block relative to the longitudinal axis of the device. The pair of torsion coil springs 216 cause the gripping arm 210 to assume an open state forming a gap at the distal end 209 of the gripping arm 210, and the gripping yoke 220 to tend to assume an off-axis state. The stapler arm 230 is attached to the stapler 240, and is attached to the inner tube 280 by a connection portion 242 that can be sequentially segmented. Accordingly, the stapler arm 230 can open and close and can pivot about 180 ° as a building block with respect to the longitudinal axis of the device 200. The pair of torsion coil springs 236 tend to cause the stapler arm 230 to assume an open state that forms a gap between the cartridge 260 and the fixed end 270, and the stapler yoke assembly 240 to tend to assume an on-axis state. The longitudinal axis of the device 200 is defined by the central axis of the inner tube 280 and the outer tube 290. Inner tube 280 and outer tube 290 allow inner tube 280 to slide and rotate within outer tube 290 so that gripping yoke 220 and stapler yoke 240 can move relative to each other about the major axis of device 200. Is built. The stapler cartridge 260 and the stapler fixed end 270 are located near the spaced distal end of each stapler arm 230. Cartridge 260 and fixed end 270 may be specially structured or may be structured according to conventional designs well known in the art.

  Small grips 250 are located at the ends of each stapler arm 230. As shown in FIGS. 25 and 26, each small grip 250 includes two opposing toothed jaws pivotally supported at one end. The small grip 250 may be constructed and activated by the small grip cable assembly 254 in a manner similar to commercially available endoscopic grips, forceps, biopsy forceps well known in the art.

  In a more preferred embodiment, either or both of the small grips 250 are replaced with a helical tissue engaging device 300, as shown in FIG. The helical device 300 has a shape very similar to a corkscrew and has a distal effector end operatively connected by a shaft to a proximal operating end that remains outside the subject in use. As shown in FIG. 27, the distal end of the tissue engaging device 300 generally has a helix 304 attached to a shaft 306 with a sharp end 308, the shaft 306 having a length. Is at least slightly flexible along, but stiff enough to transmit rotational force to helix 304, which allows helix 304 to be threaded against tissue contacted by sharp end 308. Is done. The helix 304 having the sharp end 308 is formed to engage tissue when rotated in one direction and to move away from tissue when rotated in the opposite direction. The helix 304 is typically formed of titanium, stainless steel, or similar material suitable for surgical instruments having a wire between about 0.015 inches and 0.040 inches in diameter. In a preferred embodiment, the diameter of the helix 304 wire is 0.025 inches. Examples of the diameter of the spiral 304 include a radially outer diameter of 0.080 inches to 0.250 inches, and in a preferred embodiment is 0.120 inches. The corkscrew-type tissue engaging device 300 is advanced through the movable channel of the endoscopic instrument. Alternatively, the corkscrew-type tissue engaging device 300 allows an operator to project the sharp end 308 of the helix 304 from the distal end of the outer tube 302 by a desired amount and retract into the distal end. , Are slidably disposed within the outer tube 302. Outer tube 302 may be formed from stainless steel, a polymer extruded with embedded stainless steel braid, polyethylene, polypropylene, polyimide, Teflon, or similar suitable biocompatible material. As another alternative, the corkscrew-type tissue engaging device 300 is advanced through the movable channel of the combination device 200. Such a movable channel is a hollow tube suitable for receiving a remotely operated surgical tool such as a corkscrew-type tissue engaging device 300, a needle, a grasper, a biopsy device, a brush, an electrocautery electrode, and the like. .

  In another embodiment, either or both grips 250 are replaced with a suction device as shown in FIG. "Suction" as used herein is equivalent to vacuum or reduced pressure relative to atmospheric pressure. In its simplest embodiment, as seen in FIG. 28, the suction-based tissue engaging device 400 is an open-ended tube 402 having an opening 406 at a distal end 408, wherein the tube 402 comprises a lumen It is built with axial stiffness sufficient to resist collapse when the effective vacuum force present in 404 is applied on tissue at the distal end. In another embodiment, shown in FIG. 28, the suction-based tissue engaging device 420 is a closed end tube 422 having at least one opening in a sidewall near the distal end 428, wherein the tube 422 is a lumen 404. It has sufficient axial stiffness to withstand collapse when the effective vacuum force present therein is applied on the side of the tissue. The distal or side opening 406 or 426 can include a flange 412. FIG. 28 illustrates one such embodiment, in which an opening 406 at the distal end of the open end tube 402 opens into a flange 412 in fluid communication with the lumen 404. Flange 412 may take the shape of a cone, cup, sphere, or smooth concave surface. A source of vacuum or reduced pressure may be provided by an operative connection at the proximal end 410 to any means known in the art, provided that the applied vacuum is effective at engaging tissue. And is appropriate for the purposes of the present invention. There is no limitation on such means, including commercially available vacuum pumps, "wall-mounted aspirators" used in hospital operating rooms and many medical or surgical rooms and hospital patient rooms, portable aspirators and the like. . Suitable reduced pressures for the purposes of the present invention are typically 10 to about 560 mmHg, and may vary with the size and shape of the opening.

  For the purposes of the following description, the grip 250 is understood to be non-limiting, for example, a corkscrew-like reactor 300 or a suction device 400 can be used for a similar effect.

  As shown in FIG. 26, the cable assembly 214 is coupled to the gripping arm 210, which, together with the gripping arm torsion coil spring 216, opens and closes the gripping arm 210. The tensioning gripper arm cable assembly 214 disturbs the gripper arm torsion coil spring 216 to close the gripper arm 210, and the looser gripper arm torsion coil spring 216 causes the gripper arm torsion coil spring 216 to open the gripper arm 210. Enable. Similarly, the cable assembly 234 is coupled to the stapler arm 230, which, together with the stapler arm torsion coil spring 236, allows the stapler arm 230 to open and close. The tensioned stapler arm cable assembly 234 disturbs the stapler arm torsion coil spring 236 to close the stapler arm 230, and the loose stapler arm cable assembly 234 allows the stapler arm torsion coil spring 236 to open the stapler arm 230. Enable.

  The stapler cartridge 260 is located on the distal end of one of the stapler arms 230 and is activated by the cable assembly 246 for at least one staple to be placed in the tissue. The stapler fixed end 270, located at the distal end of the other stapler arm, is juxtaposed by a taut stapler arm cable assembly 234.

  In an alternative embodiment, the stapler cartridge 260 and the stapler fixed end 270 are replaced with corresponding elements constructed to deliver the at least one two-part fastener described above. An example of a preferred embodiment of a two-part fastener is shown in FIG. The fastener includes a first part 350 and a second part 360. The first portion 350 includes a head 352 and a post 354 having a cone end that tapers to a point 356 at which tissue can be pierced. The second part 360 is an annular engaging element 362 configured to engage the post 354 with the engaging element grooved flange 364 as the point 356 advances through the engaging element opening. The grooved flange 364 includes a plurality of rigid radially extending flaps extending axially away from the head 352 on one face of the opening 366. The flaps of the grooved flange 364 allow the post 354 to be inserted from the other surface of the opening 366 through the opening 366 and prevent the post-inserted post 354 from retracting. The flaps of the grooved flange 364 radially bend outwardly to accommodate the column 354 (the diameter of the column 354 exceeds the opening 366) so that the grooved flange 364 engages the column 354. Hold. The length of the post 354 is sufficient to penetrate to the desired amount or depth and to allow engagement by the engagement element 362 for use applications. Typically, such a length is about 0.25 inches. In a preferred embodiment, the outermost diameter of the head 352 or the engaging element 362 is about 0.25 inches. The post 354 can be grooved or threaded with, for example, a 0-80 thread to provide a more secure engagement with the grooved flange 364. First part 350 and second part 360 are preferably formed from titanium, stainless steel, a biocompatible polymer, or a combination of such materials. For the purpose of the following description, the stapler cartridge 260 and the stapler fixed end 270 will be understood to be non-limiting, for example, an element configured to deliver at least one two-part fastener may have similar effects. Can be used for

  As shown in FIG. 30, the gripping arm yoke assembly 224 and the gripping arm yoke torsion coil spring 228 are coupled to the gripping arm yoke 220. The gripping arm yoke 220 and the gripping arm 210 pivot about a segmentable connection 222. When the gripper arm yoke cable assembly 224 is tightened, the gripper arm yoke torsion coil spring 228 prevents the gripper arm yoke 220 from pivoting such that the free end 209 of the gripper arm 210 pivots away from the stapler yoke 240. When the gripper arm yoke cable assembly 224 is loosened, the gripper arm yoke torsion coil spring 228 allows the gripper arm yoke 220 to pivot such that the free end 209 of the gripper arm 210 pivots relative to the stapler arm yoke 240. I do.

  Similarly, stapler arm yoke assembly 244 and stapler arm yoke torsion coil spring 248 are coupled to stapler arm yoke 240. The yoke 240 pivots about a segmentable joint 242. When the stapler arm yoke cable assembly 244 is tightened, the stapler arm yoke torsion coil spring 248 prevents the stapler arm yoke 240 from pivoting such that the free end of the stapler arm 230 pivots relative to the gripping arm yoke 220. When the stapler arm yoke cable assembly 244 is loosened, the stapler arm yoke torsion coil spring 248 allows the stapler arm yoke 240 to pivot such that the free end of the gripper arm 230 pivots away from the gripper arm yoke 220. .

  Optional features of the device shown in FIG. 31 include at least one pressure monitoring tube 500 and 520. The pressure monitor tube 500 has at least one opening 506 located near the gripping arm yoke 220 so that the pressure of the tissue at the GEJ as the instrument 200 advances to the above position can be measured. The proximal end of tube 500 is operably connected to a pressure gauge external to the subject. The pressure monitor tube 520 has at least one opening 506 located at an arbitrary position along the stapler arm 230, and can measure the yield pressure when the instrument 200 advances to the above position. The proximal end of the pressure monitor tube 520 is operably connected to a pressure gauge external to the subject. Tubes 500 and 520 are preferably formed from a biocompatible polymer and are configured to have an inside diameter of at least about 0.020 inches. The pressure monitor tube 500 terminates as a closed end tube at the distal end 504 and has an opening 506 in the side wall near the distal end 504. The pressure monitor tube 502 also terminates at the distal end 504 as a closed end tube and may have an opening 506 in a sidewall near the distal end 524. Alternatively, the pressure monitor tube 520 may terminate at the distal end 524 as an open end tube.

  Measurement of tissue pressure, yield pressure, or both pressures at the GEJ assists the operator in determining where to most advantageously engage, manipulate, and / or secure tissue. Pressure measurements can be taken at any point throughout the procedure. For example, an operator performing the described method for treating GERD measures a baseline of at least one of these pressures, engages and manipulates tissue, makes another measurement, disengages tissue, The steps of engaging, manipulating and measuring can then be repeated at least until the desired pressure is obtained. Similarly, an operator performing the described method for treating GERD measures a baseline of at least one of these pressures, engages and manipulates tissue, makes another measurement, disengages tissue, Then, at least the steps of engaging, manipulating and measuring can be repeated to determine an optimal position for engagement, an optimal operation, and / or an optimal point for fixation.

  When using the device 200 for the method of the present invention, the distal end of the device 200, including the stapler arm 230, the stapler arm yoke 240, the gripping arm yoke 220, and the gripping arm 210, has a conduit (even the esophagus 12). (Which may be a gastrostomy) into the subject's stomach 10. During the introduction of the device 200 into the stomach, the device 200 is positioned as shown in FIG. When positioned as shown in FIG. 25, the entire distal end of the device 200 is configured to pass through a hole less than about 1 inch in diameter, preferably a hole no greater than 2.0 cm in diameter. Tensioning the stapler arm cable assembly 244 causes the stapler arm yoke 240 to rotate, and relaxing the stapler arm cable assembly 234 releases the switcher arm 230 and advances the inner tube 280 within the outer tube 290. Accordingly, the device 200 takes the configuration shown in FIG.

  The two small grips 250 engage the tissue at two independent points. The tissue so engaged can be easily manipulated by tensioning the stapler arm cable assembly 234, allowing the two small grips 250 to come closer together. Using such an operation, the tissue can be supported by effectively tightening the tissue inserted between the two small grips 250. Such an operation can be useful to bring the sealing surfaces together and tighten the existing flap valve, such as in FIGS. In FIG. 15, the small grip 250 engages the tissue at points 73 and 75, and the stapler arm 230 is more closely juxtaposed by tensioning the stapler arm cable assembly 234, and the tissue 72 adjacent the existing flap valve 70. Support. At least one staple is placed in the tissue at position 77 by the stapler cartridge 260 to stabilize tissue reconstruction. Similarly, in FIG. 17, the small grip 250 engages tissue at the first pair of points 89 and 91 (or 85 and 87), and the stapler arm 230 tensions the stapler arm cable assembly 234 to the points 89 and 91. (Or 85 and 87) are more closely juxtaposed by juxtaposing them. The at least one staple is positioned by a cartridge 260 into the tissue at a respective location 93 (or 95) to stabilize the tissue. These steps are then repeated for the other pair of points.

  The two small grips 250 can bulge tissue by sliding the stapler arm yoke 240 in the desired direction of engagement, as seen, for example, in FIG. The gripping arm 86 corresponds to the stapler arm 230, the associated small grip 82 corresponds to the small grip 250, and the stapler element 84 corresponds to the stapler cartridge 260 and the stapler fixed end 270.

  A small grip 250 may advantageously be used in combination with the grip arm 210. If the distal end of the device 200 is introduced into the lumen of the stomach and assuming the configuration shown in FIG. 32 as described above, FIG. 33 shows that the small grip 250 and the grip arm 210 are open and contact with the tissue is reduced. It will be easier. After contact with the tissue, FIG. 34 shows that the grasping arm 210 closes and engages tissue near the esophageal opening 36 leading to the stomach, while the small grasping 250 moves to fold as shown in FIG. Engage point tissue. As shown in FIG. 35, the tissue so engaged may optionally pivot the gripper arm 210, pivot the stapler arm 230, and position the gripper arm yoke 220 relative to the stapler arm 240. Can be operated by combining with. In a preferred embodiment, the stapler arm 230 is closed and the stapler arm yoke 240 is pivoted. This is necessary to bring the tissue together near the distal esophagus and fold, as shown in FIG.

  Another embodiment of a tissue engagement and manipulation device 600 is shown in FIG. Apparatus 600 includes a conventional endoscope 602 on which a roller assembly 604 is supported or combined. Roller assembly 604 includes a pair of rollers 606 and 607 independently pivoted for free rotation on a pair of support arms 608. The support arm 608 is sequentially fixed to a support structure 610 connected to the endoscope 602. Each roller 606 and 607 includes a tooth 612. The teeth 612 of one roller 606 are interengaged with the teeth 612 of the other roller. However, in an alternative embodiment, the distal ends of the teeth 612 of each roller 606 and 607 can be spaced a very short distance from each other. Preferably, teeth 612 extend from rollers 606 and 607 at an angle to the radius of roller 606. However, the teeth 612 may extend radially. Rollers 606 and 607 rotate in opposite directions. In other words, when the roller 606 rotates clockwise as shown in FIG. 37, the roller 607 rotates counterclockwise as shown in FIG. In this manner, the tissue engaged by rollers 606 and 607 is captured and drawn between rollers 606 and 607 to form flaps, bulges, mounds, and the like. Preferably, once the fixation of the tissue is obtained, the direction of rotation of rollers 606 and 607 can be reversed to release the tissue. Alternatively, support structure 610 can be configured such that rollers 606 and 607 can be disengaged by vibrating apart from each other. At least one of the rollers 606 and 607 is provided by a manually operated mechanism located externally or by a servomotor (not shown) coupled to the rollers 606 and / or 607 respectively driven by a suitable cable (not shown). Driven.

  In operation, a combination of an endoscope and device 600 is placed endoscopically in the subject's stomach. Utilizing an endoscope 602, the device 604 is positioned to engage tissue at a desired location in the stomach or other trachea. Once positioned at the desired location, a manually operated mechanism or servomotor (not shown) is activated to rotate rollers 606 and 607 to engage and manipulate tissue of the desired size and shape. Thereafter, the rotation of the rollers 606 and 607 is stopped. A suitable fixation device (not shown) is placed endoscopically and fixes the reconstructed tissue in the reconstructed shape. The tissue fixation device utilized is one of the devices described above for the present invention, including a conventional stapler. When the fixing step is completed, the rotation direction of the rollers 606 and 607 is reversed, and the tissue is separated from the rollers 606 and 607. Thereafter, the device 600 may be moved to a different location in the stomach or other trachea and the above steps may be repeated.

  Because the device of the present invention is novel and is intended for use in treating human subjects, it is important to direct a physician operator to the mechanisms and methods of the device disclosed herein. . Training of the devices and methods may be performed on a cadaver or human model, and may be performed on the patient's bedside.

  In FIG. 38, an instrument 700 for reconstructing gastric tissue, for example, gastric tissue near an esophageal gastric junction (GEJ) 702, such as a minor curvature tissue 704, is shown. GEJ is the transition region from the esophagus to the stomach. The minor curvature is that part of the stomach that lies beyond the GEJ. The device 700 has a major axis 710 sized to allow oral access to the stomach and a tissue manipulator 712 for manipulating gastric tissue. A standard GI endoscope 715, which provides visual guidance of the reconstruction procedure, is located within the lumen 714 defined by the axis 710. The device 700 is particularly adapted for treating GERD. The device 700 is used to form a bulge, fold or tissue wrap near the esophagogastric junction 702 as described below to reduce reflux of gastric fluids into the esophagus.

  The tissue manipulator 712 includes a long cable assembly 716 housed within a lumen 714 of the shaft 710 and a distal end effector 718 driven to perform various steps in a tissue reconstruction procedure with the cable assembly 716. Have. End effector 718 includes first and second jaws 720, 722 that engage tissue 704. As described further below, the cable assembly 716 includes first and second pairs, 724a, 724b, and 726a, for moving the jaws 720, 722, respectively, spaced apart from each other on the first surface. 726b, as well as a third cable 728 for moving the end effector 718 relative to a second plane axis 710 that is generally transverse and preferably perpendicular to the first plane. During insertion into the stomach, end effector 718 aligns with axis 710 (shown in FIG. 40A). Once positioned in the stomach, drive the cable 728 to segment the end effector 718 from alignment with the shaft 710 (shown in FIG. 38).

  The cable assembly 716 has a spring crosspiece 784 formed, for example, from stainless steel and extending into the shaft 710. The end effector 718 is attached to the crosspiece 784 at the distal end 785 of the crosspiece 784. The cross members 784 are deflected into a linear alignment in the rest state. When the cable 728 is pulled, the cross member 784 bends. When the cable 728 separates, the crosspiece 784 returns to linear alignment.

  In FIG. 39, the tissue fixing portion, for example, the first portion 732 of the fixing device 730 is supported by the first holding portion 720, and the second portion 734 of the tissue fixing device 730 is supported by the second holding portion 722. As further described below, after the jaws 720, 722 engage the tissue 704 and manipulate the tissue 704 in a lapping action to form a bulge 736, for example, in a minor curvature, the tissue fixation device 730 Is deployed (deployed) to secure the engaged tissue. Cable assembly 716 includes a fourth cable for deploying fixation device 730, as further described below.

  End effector 718 further includes a tube 738 and a third tissue engaging portion, such as a coil 740, housed within tube 738 for purposes described below. Coil 740 is housed within outer tube 742, and coil 740 and outer tube 742 can move proximally and distally axially with respect to jaws 720 and 722 along axis A of cable assembly 716. . Coil 740 can be rotationally advanced toward tissue.

  In FIG. 40A, the instrument 700 has a handle 743 at the proximal end 745, the handle 743 having an operating knob 744 for operating the cables 724a, 724b, 726a and 726b to open and close the jaws 720 and 722. And an operation knob 746 for operating the cable 728 to move the end effector 718. The handle 743 has a portion 748 that allows the coil 740 and outer tube 742 to be introduced into the shaft lumen 714, as described below, and a pull knob for deploying the tissue fixation device. As shown in FIG. 40B, handle 743 defines a channel 752 through which endoscope 715 is introduced into axial lumen 714.

  FIGS. 38 and 40C show the movable channel of the shaft 710 to accommodate the various cables, outer tube 742 and endoscope 715, and within the lumen 714 of the shaft 710, the jaws 720, 722 are shown. Cable housings 760a, 760b defining channels 762a, 762b in which cables 724a, 724b for closing are accommodated, and channels 766a, 766b in which cables 726a, 726b for opening holding portions 720, 722 are accommodated. There is a cable housing 764a, 764b to define. Also within the lumen 714 is a cable housing 768 defining a channel 770 in which a cable 728 for bending the end effector 718 is accommodated, and a channel 774 in which a cable 737 for deploying the fixation device 730 is defined. And a cable housing 772 to be used. Coil 740 and outer tube 742 are housed in a channel 778 defined in coil housing 776 within lumen 714. Housing 776 extends from section 748 to tube 738. As shown in FIG. 40D, coil 740 has a tissue piercing end 741 and a distal section 740a having a coil that is more loosely wound than the remainder of coil 740. Endoscope 715 is housed in a channel 782 defined in endoscope housing 780 within lumen 714.

  A spring crosspiece 784 is generally located between the cable housing 776 and the endoscope housing 780 such that the crosspiece 784 is pivoted from the distal end of the shaft supported on the shaft 710 by, for example, a silicone adhesive / sealant. It extends about 4 inches into 710. The various cable housings and spring crosspieces 784 do not move relative to shaft 710 and handle 743. Movement of the cable within the cable housing drives the end effector 718. Shaft 710 is preferably formed, for example, from a heat-shrinkable tube.

  Also, in FIG. 40A, the end effector 718 has a length (L1) of about 2 inches and the cable assembly 716 extends axially from the shaft 710 for a length (L2) of about 2.5 inches. The shaft 710 has a length (L3) of about 23.5 inches and the handle has a length (L4) of about 5 inches. Cable assembly 716, spring crosspiece 784, and shaft 710 have the necessary flexibility to allow oral placement of device 700 in the stomach. The length (L1) of the relatively rigid end effector 718 is minimized to ensure that the required flexibility of the instrument 700 is maintained. The cable assembly 716 selects a distance extending axially from the shaft 710 to overhang the crosspiece 784 and allow for the desired curvature of the end effector 718 relative to the shaft 710 and to the stomach lining near the GEJ. The holding parts 720 and 722 are arranged.

  The size of the distal end effector 718 is defined to fit a channel having a diameter of 12-16 mm (corresponding to the diameter of the esophagus), the shaft 710 having an outer diameter of about 12-16 mm, and It is guaranteed to pass orally into the stomach. The diameter of the viewing instrument channel is either about 8 mm or 10 mm. An approximately 8 mm diameter viewing instrument channel allows passage through a 7.9 mm pediatric gastroscope, and a 10 mm diameter viewing instrument channel allows passage through a 9.8 mm adult gastroscope. Channel 778 has a diameter of about 2-3 to accommodate cable 742.

  Further details of the distal end effector 718 are shown in FIGS. 41A and 41B. End effector 718 has a central mount 800 that defines a slot 801. A pin 803 pivotally supporting the holding portions 720 and 722 penetrates the slot 801 and is supported by the mount 800. The center mount 800 also houses two pulleys through which each of the cables 724a, 742b has been passed to close the jaws 720 and 722. Cables 724a, 724b terminate at points 804, 806 on clamps 720, 722, respectively. Cables 726a, 726b opening clamps 720, 722 terminate at points 808, 810 on clamps 720, 722, respectively, proximal to points 804, 806, respectively. Tube 738 of end effector 718 for receiving coil 740 and outer tube 742 is attached to mount 800, and cable 728 for bending end effector 718 terminates at point 811 on tube 738.

  As the cables 724a, 724b are pulled, the grippers 720, 722 move proximally in a direction generally facing each other on the first surface (on the paper of FIG. 41A). As the cables 726a, 726b are pulled, the grippers 720, 722 move proximally in the first plane, generally in a direction away from each other. Upon pulling the cable 728, the end effector 718 bends proximally the crosspiece 784 traveling (outside of the plane of FIG. 41A) in a second plane, generally perpendicular to the first plane.

  In FIG. 42, the holding portion 720 has two guide tubes 816a and 816b, and a cylinder 812 including two push rods 814a and 814b guided in the tubes 816a and 816b, respectively. The cylinder 812 is supported by the holding portion 720 and slides with respect to the holding portion 720. Tubes 816a and 816b curve around pinch 720 and terminate at tissue piercing ends 818a and 818b, respectively (FIG. 43B). The push rods 814a, 814b may be formed from molded plastic, such as polyethylene or polypropylene, or braided stainless steel cables to provide flexibility to follow the curves of the tubes 816a, 816b. The cable housing 772 is attached to the slider 812, and the cable 737 ends at a fixed point 739 on the holding portion 720. Driving cable 737 pushes slider 812 distally as described below.

  FIGS. 43A and 43B show the first portion 732 of the tissue fixation device 730 in more detail. The first portion 732 of the tissue fixation device 730 defines through holes 820a, 820b (FIG. 43A), and the first portion 732 is clamped at ends 818a, 818b that are received through the holes 820a, 820b, respectively. Loaded on top. Two securing elements, eg, rods 824a, 824b, are connected to the first portion 732 with sutures 822. Each bar 824a, 824b defines two through holes 826a, 826b. Suture 822 is threaded through holes 826a, 826b in the rod and holes 820a, 820b in first portion 732 and tied to form knot 823, and bars 824a, 824b are attached to first portion 732. Fix it. Tubes 818a, 818b each define a channel 827 for receiving one of rods 824a, 824b and a slot 828 that communicates with channel 827 for receiving suture 822.

  In particular, in FIGS. 41B and 44, the jaw 722 has a distal portion 830 that includes a slot 832 for receiving a second portion 734 of the fixation device 730 and tissue piercing ends 818a, 818b. Slots 834a, 834b for receiving are defined. The second portion 734 of the fixation device 730 defines through holes 836a, 836b for receiving the ends 818a, 818b. When the jaws 720, 722 are closed, the ends 818a, 818b pass through the slots 834a, 834b and the holes 836a, 836b. When the fixing device deploying cable 737 is driven after the holding portions 720 and 722 are closed, as shown in FIG. 45, the slider 812 and the push rods 814a and 814b are pushed distally, and the rods 824a and 824b are moved to the tissue penetrating ends 818a. , 818b, the rods 824a, 824b are located on the far side 838 of the second part 734 of the fixation device 730.

  46A-46F, using the endoscopic guide, the physician orally advances the instrument 700 to position the end effector 718 inside the stomach. While advancing to the stomach, the end effector 718 is generally aligned along the axis of the shaft 710, as shown in FIG. 46A. The physician then operates the knob 746 to pull the cable 728 proximally, thereby bending the crosspiece 784 and disengaging it from the end effector 718 shaft 710 to the position shown in FIG. 46B. Next, the operating knob 744 is rotated to pull the cables 726a and 722, and the holding portions 720 and 722 are pivoted about the pin 803 to the opening position shown in FIG. 46C.

  The physician then advances coil 740 and outer tube 742 out of tube 738 by pushing the coil and outer tube distally in channel 778 advancing coil 740 and outer tube 742, as shown in FIG. With the gastric tissue, preferably beyond the esophagogastric junction. When the outer tube 742 is pressed against the tissue to secure the tissue, the physician rotates the coil 740 while applying a slight distal pressure to advance the coil into the tissue, as shown in FIG. 46D. Let it. The coil 740 and outer tube 742 are then pulled proximally, pulling the tissue between the clamps 720 and 722. Then, as shown in FIG. 46E, the holding knobs 720 and 722 are closed by rotating the operation knob 744 and pulling the cables 724a and 724b proximally. Turning the operating knob also has the effect of pulling the coil 740 and the outer tube 742 proximally, ensuring that the coil 740 and the outer tube 742 are positioned without going through the blockages 720, 722. When the coil 740 and the outer tube 742 are not located proximal to the clamps 720, 722, a lockout can be incorporated to prevent the clamps 720, 722 from being blocked.

  Upon closure of the clamp, first portion 732 and second portion 734 of fixation device 730 contact two tissue sections (eg, two spaced tissue surfaces in the stomach) and tissue piercing ends 818a, 818b. Penetrates the tissue and through the holes 836a, 836b of the second portion 734 of the fixation device 730. To deploy the fixation device 730, the physician pulls the cable 737 proximally to remove any slack from the cable 737. Since the cable housing 772 has a fixed length and is immovably attached to the handle, the cable housing 772 moves distally when the cable 737 is slackened as shown in FIG. 46F. Then, the slider 812 advances, and the external “t” -shaped rods 824a and 824b are pushed from the tissue piercing ends 818a and 818b.

  The physician then releases the jaws 720, 722, disengages the jaws 722 from the second portion 734, returns the distal end effector to its original position, generally aligned by the shaft 710, and closes the jaws. The device 700 is taken out. FIG. 47 shows a cross-sectional view of a tissue having a fixation device 730 where the bulge 736 is fixed.

  Other embodiments are within the scope of the following claims.

  For example, instead of a coil 740, an alternative tissue penetrating or grasping element, such as a T-suture or two small grasping jaws, could be used. The device 700 can be used without a third tissue engaging portion.

  The hiatal hernia can also be cured as described above using the instrument and fixation device described in FIG.

FIG. 3 is a pictorial illustration of an anterior-posterior incision of the stomach, with the gastroscope advanced from the esophageal lumen to the stomach lumen and inverted to visualize GEL. FIG. 2 is a pictorial illustration of the stomach of FIG. 1 with the tissue engaging device inside the lumen of the stomach. FIG. 3 is a pictorial view of the stomach of FIG. 2, showing the tissue engaging device engaged with a portion of the stomach wall and invaginated. A pictorial cross-section of the stomach looking in the direction of the opening from the esophagus to the stomach, showing tissue engagement at two locations, with arrows pointing over the engaged tissue to create a tissue intussus covering the GEJ Indicates the direction of the force. A pictorial cross-section of the stomach looking into the direction of the opening from the esophagus to the stomach shows the invaginated tissue intussusception covering the GEJ. A cross-sectional view of the stomach looking in the direction of the opening from the esophagus to the stomach shows a situation in which the invaginated triangular tissue intussusception covering the GEJ is viewed. FIG. 4 is a pictorial illustration of the stomach of FIG. 3, with the endoscopic tissue fixation device also introduced through the esophagus into the lumen of the stomach. Fig. 3 is a pictorial illustration of an anterior-posterior incision of the stomach, showing one tissue fixation device positioned to engage an invaginated portion of the stomach wall. FIG. 2 is a pictorial view of a stomach showing a row of tissue fixation devices. FIG. 2 is a pictorial view of a stomach showing a three-row tissue fixation device. FIG. 2 is a pictorial illustration of a stomach showing a non-parallel row of tissue fixation devices. FIG. 3 is a pictorial view of the stomach showing the tissue fixation devices arranged in a triangle. FIG. 2 is a pictorial view of a stomach showing a plurality of tissue fixation devices arranged in a curved row. FIG. 4 is a cross-sectional view of the stomach looking in the direction of the opening from the esophagus to the stomach, showing a flap valve between a normal stomach and the esophagus. Figure 4 is a cross-sectional view of the stomach looking in the direction of the opening from the esophagus to the stomach, showing the invaginated tissue bulge facing the flap of the flap valve between the normal stomach and the esophagus. FIG. 3 is a cross-sectional view of the stomach looking in the direction of the opening from the esophagus to the stomach, showing one method of aligning the sealing surface with the existing flap valve between the stomach and the esophagus. FIG. 4 is a cross-sectional view of the stomach looking at the direction of the opening from the esophagus to the stomach, showing a method of reinforcing an existing flap valve between the stomach and the esophagus. FIG. 7 is a cross-sectional view of the stomach looking at the direction of the opening from the esophagus to the stomach, showing a situation where the invaginated tissue is fixed at its base with three tissue fixing devices. FIG. 4 is a cross-sectional view of the stomach looking in the direction of the opening from the esophagus to the stomach, showing a rectangular tissue invagination fixed at its base covering the GEJ. FIG. 2 is a pictorial view of the stomach of FIG. 1 showing a combination of a tissue engaging device and a tissue fixation device advanced through the lumen of the esophagus into the lumen of the stomach. 21 is a diagram pictorially showing the stomach of FIG. 20, showing the situation after creation and addition of two locations on the stomach wall. FIG. FIG. 21 is a diagram pictorially showing the outside of the stomach of FIG. 20, showing the operation direction of the stomach tissue viewed from the inside. FIG. 23 is a pictorial illustration of the stomach of FIG. 22, showing fixation between invaginated locations of the stomach wall. FIG. 24 is a pictorial illustration of the stomach of FIG. 23, illustrating fixation of the septum between invaginations of the stomach wall. FIG. 2 illustrates a preferred embodiment of a tissue engaging / manipulating / fixing device according to the present invention. FIG. 26 schematically shows a three-dimensional side view of a part of the device of FIG. 25. FIG. 3 is a pictorial view of a cork opener tissue engaging device. A pictorial illustration of the open end tube suction tissue engaging device (top), a closed end tube suction tissue engaging device (center), and an open end and flanged tube suction tissue engaging device. (Below). FIG. 2 is a pictorial view of a two-part tissue fixation device. FIG. 26 is a partial three-dimensional side view schematically illustrating the apparatus of FIG. 25. FIG. 26 is a three-dimensional side view showing a preferred embodiment of the tissue engaging / manipulating / fixing device according to the present invention shown in FIG. 25 and further including a pressure monitoring tube. FIG. 26 is a three-dimensional side view of the device of FIG. 25, illustrating one position of the arm. FIG. 26 is a three-dimensional side view of the device of FIG. 25, showing another position of the arm. FIG. 26 is a three-dimensional side view of the device of FIG. 25, illustrating yet another position of the arm. FIG. 26 is a three-dimensional side view of the device of FIG. 25, illustrating yet another position of the arm. 26 is a schematic, partial cutaway view of the stomach showing the use of the device of FIG. 25 therein. FIG. 2 is an overhead view of a tissue engaging device equipped with opposed rollers. FIG. 2 illustrates a device being used to reconstruct tissue near the gastroesophageal junction of the stomach. FIG. 2 illustrates a tissue fixation device positioned by the device of FIG. 1 used to fix a bulge formed in tissue. It is explanatory drawing of the apparatus of FIG. FIG. 4 shows the proximal end of the device. It is a figure which shows the working passage of the shaft of the said apparatus. It is explanatory drawing of the coil assembly of the said apparatus. FIG. 4 is a plan view of the distal end of the device, showing the first and second gripping members in an open position. FIG. 4 shows the distal end of the device in an off-axis position of the device. FIG. 41B is a side view showing the distal end of the device rotated 90 degrees with respect to FIG. 41A. FIG. 40 is an explanatory view showing a first portion of the tissue fixing device of FIG. 39. It is explanatory drawing which shows the said 1st holding member and the 1st part of the tissue fixation apparatus mounted in the said holding member. It is explanatory drawing of the said 2nd holding member. FIG. 40 is an explanatory view of the tissue fixing device of FIG. 39. FIG. 39 is a diagram showing a situation during use of the device of FIG. 38. FIG. 39 is a diagram showing a situation during use of the device of FIG. 38. FIG. 39 is a diagram showing a situation during use of the device of FIG. 38. FIG. 39 is a diagram showing a situation during use of the device of FIG. 38. FIG. 39 is a diagram showing a situation during use of the device of FIG. 38. FIG. 39 is a diagram showing a situation during use of the device of FIG. 38. FIG. 40 is an explanatory diagram of a tissue fixed by the tissue fixing device of FIG. 39.

Claims (31)

A first member and a second member operably configured at a distal portion of the flexible device,
The first member includes a tissue fixing device having two fixing components connected by a flexible member,
An apparatus wherein the first member and the second member interact to position the tissue fixation device within a patient, wherein the two fixation components are positioned at a predetermined relative distance.   The apparatus according to claim 1, wherein the flexible member is formed of a different material from the fixed component.   The device of claim 1, wherein the flexible member comprises a suture.   The apparatus of claim 1, wherein each of the securing components defines a hole for receiving the flexible member.   The device of claim 1, wherein the second member comprises a portion of the tissue fixation device.   The apparatus of claim 1, wherein the first member defines two channels for receiving the two fixed components at the predetermined relative distance.   7. The device of claim 6, wherein the first member further comprises two tissue piercing elements each defining the two channels.   The device of claim 7, wherein the second member defines two holes for receiving the two tissue piercing elements, respectively.   The apparatus according to claim 1, wherein the two fixed parts are connected to the first member at the predetermined relative distance. A tissue fixing device having a fixing portion coupled by a flexible portion, comprising a member configured to penetrate living tissue,
An apparatus wherein the member is operably configured at a distal portion of a flexible device and positions the fixation portion of the tissue fixation device at a predetermined relative distance through the living tissue.   The device of claim 10, wherein the flexible portion is formed of a different material than the fixed portion.   The device of claim 10, wherein the flexible portion comprises a suture.   The apparatus of claim 10, wherein each of the fixed portions defines a hole for receiving the flexible portion.   The device of claim 10, further comprising a second member including a portion of the tissue fixation device.   The apparatus of claim 10, wherein the member defines a channel that houses the fixed portion at the predetermined relative distance.   The device of claim 15, wherein the member comprises an element defining the channel and piercing the biological tissue.   17. The device of claim 16, further comprising a second member defining a hole for receiving the element.   The apparatus according to claim 10, wherein the fixed portion is coupled to the member at the predetermined relative distance. Two tissue piercing elements,
A tissue fixation device including a fixation portion joined by a flexible portion;
With
The fixed portion and the flexible portion are formed of different materials,
The two tissue-piercing elements are configured such that the fixation portion of the tissue fixation device can be placed through living tissue.   20. The device of claim 19, wherein the flexible portion comprises a suture.   20. The device of claim 19, wherein each of the securing portions defines a hole for receiving the flexible portion.   20. The device of claim 19, wherein the two tissue piercing elements define a channel that houses the fixation portion. Two tissue piercing elements,
A tissue fixation device including a fixation portion joined by a suture;
With
The two tissue-piercing elements are configured such that the fixation portion of the tissue fixation device can be placed through living tissue.   24. The device of claim 23, wherein each of the fixation portions defines a hole for receiving the suture.   24. The device of claim 23, wherein the two tissue penetrating elements define a channel that houses the fixation portion. A coil shaft having flexibility;
A tissue piercing coil located at a distal end of the coil shaft;
With
The medical device, wherein the tissue piercing coil is wound in a manner different from at least a part of the coil shaft.   The medical device according to claim 26, further comprising a member disposed beyond the coil shaft.   The medical device according to claim 27, wherein the member and the coil shaft are configured to be relatively movable.   The medical device according to claim 27, wherein the member is configured to be capable of fixing tissue. An elongated and flexible coil shaft;
A tissue piercing coil located at a distal end of the coil shaft;
A member arranged beyond the coil shaft;
With
The medical device, wherein the member and the coil shaft are configured to be relatively movable. 31. The medical device according to claim 30, wherein the member is configured to fix a tissue.